What is CLN-978 studying for Systemic Lupus Erythematosus (SLE)?

CLN-978 is being studied to evaluate its safety and tolerability in adults with moderate to severe SLE who have not responded well to standard treatments. The trial assesses its effects on the immune system by targeting CD19-positive B cells. Cullinan Therapeutics Inc. sponsors this research to explore new treatment options for SLE.

Who may be eligible for this Systemic Lupus Erythematosus clinical trial?

Adults aged 18 to 70 years with a confirmed diagnosis of SLE for at least 24 weeks may be eligible. Participants must have active disease with specific antibody markers and have had an inadequate response to certain standard treatments. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this Systemic Lupus Erythematosus clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Participants are responsible for personal travel expenses, which may vary and are not guaranteed to be covered. This helps ensure access to the study treatment and evaluations during the trial.

Actively Recruiting

Phase 1

Age: 18Years - 70Years

All Genders

ID06613360

Phase 1b Open-label Study of CLN-978 Given Under the Skin for Adults With Moderate to Severe Systemic Lupus Erythematosus

Led by Cullinan Therapeutics Inc. · Updated on 2026-06-05

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating CLN-978, a subcutaneously administered CD19-directed T cell engager, in adults with moderate to severe Systemic Lupus Erythematosus SLE. This Phase 1b open-label pilot study aims to assess the safety and tolerability of CLN-978 in patients who have active SLE with inadequate response to standard treatments, including corticosteroids, antimalarials, immunosuppressants, or biologics. The study is sponsored by Cullinan Therapeutics Inc. and plans to enroll adults aged 18 to 70 years. Participants will receive CLN-978 administered by subcutaneous injection in two parts Part A involves dose escalation cohorts to determine safe dosing levels, and Part B further evaluates treatments at higher doses or extended schedules for eligible patients from Part A. The treatment duration includes up to 48 weeks of monitoring with specified dosing days. Patients must meet defined laboratory and disease activity criteria to participate, and those in Part B must have had no dose-limiting toxicity or treatment discontinuation in Part A and wait at least 90 days after the last dose. During the study, participants will undergo regular safety and tolerability assessments, including laboratory tests to monitor blood cell counts, kidney and liver function, and immune response markers. Pharmacokinetics, immunogenicity, and pharmacodynamics biomarkers related to treatment effects will also be evaluated over 48 weeks. The study aims to monitor adverse events closely and ensure ongoing assessment of treatment impact on disease activity and patient well-being throughout the trial.

CONDITIONS

Brief Title

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of SLE at least 24 weeks before screening and meeting 2019 EULAR / ACR Classification Criteria
Presence of one or more autoantibodies: positive anti-nuclear antibody (ANA) test (≥1:80), anti dsDNA above upper limit of normal, or anti-Sm above upper limit of normal
Active SLE disease with SLEDAI total score ≥6 at screening
Inadequate response to at least two treatments including oral corticosteroids, antimalarials, conventional immunosuppressants, or biologics; at least one failed treatment must be immunosuppressive or biologic
Stable dose of corticosteroid and/or antimalarial prior to day 1 if applicable
Laboratory requirements: absolute lymphocyte count ≥0.5 x 10^9/L, peripheral B cell count ≥25 cells/μL, absolute neutrophil count ≥1.0 x 10^9/L, hemoglobin ≥8 g/dL, platelet count ≥75 x 10^9/L, estimated glomerular filtration rate ≥30 mL/min/1.73m2, total bilirubin ≤1.5 × upper limit of normal except Gilbert's Syndrome, AST and ALT ≤2.5 × upper limit of normal
For Part B: patients treated in Part A without dose-limiting toxicity or discontinuation due to adverse events, eligible for retreatment at higher dose or longer schedule after at least 90 days since last dose

You will not qualify if you...

Active inflammatory disease other than SLE, except thyroiditis or secondary Sjogren's syndrome
Considered at high risk for thrombosis
Rapidly progressive glomerulonephritis or urine protein/creatinine >3 mg/mg (339 mg/mmol)
Active severe neuropsychiatric or central nervous system manifestations of SLE
Evidence of hepatitis B, hepatitis C, HIV, Epstein-Barr virus, or cytomegalovirus infection
History of splenectomy
Prior treatment with cellular or gene therapy products targeting any target
Investigational therapy use within 30 days or 5 drug-elimination half-lives before Day 1
Anti-CD19 or anti-CD20 therapy within 3 months before Day 1
Non-biologic DMARD within 14 days before Day 1
Cyclophosphamide within 1 month or biologic immunomodulating therapy within 2 months before Day 1
Live or attenuated vaccine within 28 days before or during screening
Active significant infections including SARS-CoV-2 within 14 days before Day 1
Active or latent tuberculosis unless previously treated and no current symptoms
Any condition that may interfere with study assessments or patient safety as judged by Investigator or Sponsor

Research Team

Meagan Sardinha

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Phase 1b Open-label Study of CLN-978 Given Under the Skin for Adults With Moderate to Severe Systemic Lupus Erythematosus

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria